Gel-Tin Fluoride

DESCRIPTION:

Self-applied 0.4% stannous fluoride dentifrice for use in dental caries prevention.

Active Ingredient: 0.4% stannous fluoride

CLINICAL PHARMACOLOGY:

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

INDICATIONS AND USAGE:

Aids in dental caries prevention. Once daily self-applied topical use. It is well established that 0.4% stannous fluoride is safe and extraordinarily effective in caries prevention when applied frequently to the tooth surfaces. This prescription fluoride supplement should be used once daily unless otherwise instructed by your dental professional. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

CONTRAINDICATIONS:

Do not use in patients with dysphagia (swallowing problems). Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

WARNINGS:

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially if the water fluoridation exceeds 0.6 ppm, since younger pediatric patients frequently cannot perform the brushing process without significant swallowing. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of toothpaste which could cause dental fluorosis. Pediatric patients under age 12 should be supervised in the use of this product. Read directions carefully before using. Keep out of reach of infants and children.

PRECAUTIONS:

General: Not for systemic treatment. DO NOT SWALLOW

DOSAGE AND ADMINISTRATION:

Follow these instructions unless otherwise instructed by your dental professional:

1. Adults and pediatric patients 6 years of age or older, after brushing and flossing apply a thin ribbon of Gel-Tin to a toothbrush. Brush all tooth surfaces thoroughly for one minute, preferably at bedtime.

2. After use, adults expectorate. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16, expectorate after use under adult supervision. If there are any doubts that expectoration was inadequate, rinse the mouth thoroughly with water.